Sensor External Flow Sensor, Ped/InfantRecalls & reported problems
Respironics, Inc. · External Flow Sensor, Pediatric / Infant · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959050846), received between Oct 14, 2020 and Mar 3, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Contamination2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2021Contamination; Mechanical Problem; Contamination; Mechanical Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S EXTERNAL FLOW SENSOR FAILED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER RECEIVED THE EXTERNAL FLOW SENSOR FOR EVALUATION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE EXTERNAL FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. THERE WAS EVIDENCE OF CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11406545 ↗MalfunctionOct 14, 2020Contamination; Mechanical Problem; Contamination; Mechanical Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FLOW SENSOR STOPPED WORKING WHILE BEING USED WITH A TRILOGY EVO. THE PATIENT DID NOT HAVE A BACK UP VENTILATOR TO USE SO THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10677617 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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